Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-10338 - Non-sub Change Request Memo Appeals.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-10	Available
CMS-10338 - Non-sub Change Request Memo Appeals.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-10	Repair queued
CMS-10338 - Crosswalk of changes to Appeals - .docx	Supplementary Document	Uploaded 2025-04-10	Available
CMS-10338 - Crosswalk of changes to Appeals - .docx	Supplementary Document	Uploaded 2025-04-10	Missing upstream
Non-sub Change Request Memo (CMS-10338_Appeals PRA)_clean.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-12-12	Available
Non-sub Change Request Memo (CMS-10338_Appeals PRA)_clean.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-12-12	Missing upstream
CMS-10338- 60-day Comments Response Summary_FINAL.pdf	Supplementary Document	Uploaded 2022-05-09	Available
CMS-10338- 60-day Comments Response Summary_FINAL.pdf	Supplementary Document	Uploaded 2022-05-09	Missing upstream
CMS-10338 - Supporting_Statement_2022_Final.pdf	Supporting Statement A	Uploaded 2022-05-09	Available
CMS-10338 - Supporting_Statement_2022_Final.pdf	Supporting Statement A	Uploaded 2022-05-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
249636	Internal Claims and Appeals and External Review Procedures		Unchanged
193861	Burden Estimates - Appeals	Other-Model - Notice of Internal Adverse Benefit Determination	Modified

ICR Details

OMB Control No: 0938-1099	ICR Reference No: 202504-0938-011
Status: Historical Active	Previous ICR Reference No: 202412-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/16/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/11/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2025	06/30/2025	06/30/2025
Responses	516,581,066	0	516,581,066
Time Burden (Hours)	1,198,692	0	1,198,692
Cost Burden (Dollars)	149,806,832	0	149,806,832

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Abstract: These interim final regulations set forth rules implementing revisions to the Public Health Service (PHS) Act section 2719 for internal claims and appeals and external review processes to implement Section 110 of the No Surprises Act (NSA), which protects participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from receiving surprise medical bills when they receive emergency services, non-emergency services from non-participating providers at participating facilities, and air ambulance services, under certain circumstances. Specifically Section 110 of the NSA amends section 2719 of the PHS Act to require the external review process to apply to participants, beneficiaries, and enrollees of such plans with respect to any adverse determination by a plan or issuer under section 2799A-1 or 2799A-2 of the PHS Act. These protections also extend to grandfathered plans.

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Authorizing Statute(s): PL: Pub.L. 110 - 110 No Surprises Act Name of Law: Consolidated Appropriations Act, 2021
   US Code: 45 USC 147.136 Name of Law: Internal claims and appeals and external review processes
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 110 No Surprises Act Name of Law: Consolidated Appropriations Act, 2021
US Code: 45 USC 147.136 Name of Law: Internal claims and appeals and external review processes

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 8016	02/11/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 26760	05/05/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Burden Estimates - Appeals
Internal Claims and Appeals and External Review Procedures

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	516,581,066	516,581,066	0	0	0	0
Annual Time Burden (Hours)	1,198,692	1,198,692	0	0	0	0
Annual Cost Burden (Dollars)	149,806,832	149,806,832	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $79,022

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/11/2025

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